Senior Quality Systems Manager

il y a 1 semaine


Bruxelles, Région de Bruxelles, Belgique Michael Page Temps plein

As the Successful Sr Quality System Manager - Medtech - you will have the following responsibilities:

  • Support the International organization to ensure an adequate and effective quality management system, supports the quality policy and sustains a quality
  • Lead and manage Quality Systems activities including audit readiness.
  • Lead and manage specifically the Document Management, Record Management, Training Management, CAPA, QNC, Field Action, and Supplier Quality Management quality systems in the region.
  • Provide strategic and tactical vision and consultation toward the quality system development and implementation.
  • Provide strategic and executive support to ensure alignment within the International Organization.
  • Manage communications with the organization's Certification Body regarding all quality systems related activities and issues, including planning and responding to audits.
  • Develop objectives and key performance indicators and tenaciously pursue
  • Maintain state of the art knowledge in the quality related fields
  • Leads the implementation, maintenance and training for relevant quality systems and tools, compliant to internal and external requirements, to meet business needs.
  • Respond to customer needs in an accurate and timely fashion
  • Provide leadership for quality system development, and ongoing process improvements.
  • Initiate, develop and implement new quality concepts, tools and strategies to improve business systems, practices, and assure business objectives are met.
  • Communicate project strategy and status to superiors and peers in a way that is timely, concise, accurate and responsive.
  • Work in close cooperation with the Regulatory team.

As the Successful Sr Quality System Manager - Medtech - you will have the following requirements:

  • At least a Bachelor's degree in a science, business, engineering, or related
  • At least 10 years of related experience in the medical device or pharmaceutical industry managing quality systems.
  • Analytical & detail oriented, team player.
  • Excellent communication, problem solving and management skills are required.
  • Proven Experience with CAPA, Change Management, Supplier Quality Assurance, and Risk Management is required.
  • Position requires strong knowledge of MDD 93/42/EEC / MDR 2017/745, ISO 9001, and ISO 13485 requirements
  • Ideally knowledge also on FDA, cGMP
  • Experience in MS Office and Teams
  • Excellent verbal and written English communication
  • Experience with managing CE-marking and EU Regulatory Affairs

As the Successful Sr Quality System Manager - Medtech - you will have:

  • A complete and attractive salary package in line with your experience (Base salary, Bonus, Company Car, Net allowances, Insurances, etc.)
  • The chance to join a market leader with high people value
  • Join a company that values and offers multiple career opportunity locally & globally

  • Quality Assurance Manager

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Uni Systems Temps plein

    At Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for a Quality Assurance Manager to join our UniQue team in Brussels.What will you be bringing to the team? Elaboration and maintenance of IS quality control procedures. Provision of quality plans and service level agreements. IS Quality...


  • Bruxelles, Région de Bruxelles, Belgique SERB nv Temps plein

    Senior Quality Assurance Officer / Deputy Qualified Person Scope: SERB SA – Belgium & International / activities GMDP / ISO Rôle / role The Senior Quality Assurance Officer / Deputy Qualified Person (Sr QAO/QP) assists the Quality Director/QP of SERB SA as a senior member of the local quality team, with the execution of the company's quality management...

  • Quality Assurance Lead

    il y a 1 semaine


    Bruxelles, Région de Bruxelles, Belgique Uni Systems Temps plein

    Elaboration and maintenance of information systems quality control procedures. Create quality measurements/KPIs to track improvements in products/solutions. Provision of quality plans and service level agreements. Information Systems quality control and evaluation. Provision of quality studies, quality assessments or other quality matters associated with...


  • Bruxelles, Région de Bruxelles, Belgique SERB nv Temps plein

    Senior Quality Assurance Officer / Deputy Qualified Person Scope: SERB SA – Belgium & International / activities GMDP / ISO* Rôle / role The Senior Quality Assurance Officer / Deputy Qualified Person (Sr QAO/QP) assists the Quality Director/QP of SERB SA as a senior member of the local quality team, with the execution of the company's quality management...

  • Site Quality Senior Manager

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Catalent Temps plein

    For Our Brussels branch and reporting to the QA Director, we are seeking a highly skilled and motivated Site Quality Senior Manager to join our team. You will have a vital role in ensuring the overall quality and compliance of our organization's operations. The ideal candidate will be in charge of identifying, evaluating, and managing risks associated...

  • Quality Systems Specialist

    il y a 1 semaine


    Bruxelles, Région de Bruxelles, Belgique Terumo BCT, Inc. Temps plein

    JOB SUMMARYWork under limited supervision to provide quality support by assisting management institutionalize compliance with global regulatory requirements. The Specialist must be capable of managing elements of the Quality Management Systems (QMS) to ensure timeliness of reports and compliance with the established standards. Providing support for audits,...


  • Bruxelles, Région de Bruxelles, Belgique Organon Temps plein

    For our Distribution & Supply Chain Quality team we are currently recruiting for the role of Senior Specialist Quality Assurance - Supply Chain Hub 3PL Quality Oversight.Purpose of the roleIn the role of Senior Specialist Quality Assurance - Supply Chain Hub 3PL Quality Oversight you will manage the collaboration and relation with our regional Third Party...


  • Bruxelles, Région de Bruxelles, Belgique Vertex Temps plein

    Job DescriptionGeneral position summary: The Responsible Person (Senior Manager), GDP Operations Quality, Benelux Role is responsible for ensuring the quality system is in place meeting the requirements of GDP and act as both Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA) of Vertex Pharmaceuticals (Belgium) and Vertex...

  • Quality Manager

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Siemens Temps plein

    Siemens Mobility is leader in transport solutions for more than 160 years, constantly innovating its portfolio in its core areas of rolling stock, rail automation and electrification, turnkey systems, intelligent traffic systems as well as related services. With digitalization, Siemens Mobility is enabling mobility operators worldwide to make infrastructure...

  • Quality Associate

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Telix Pharmaceuticals (EMEA) Temps plein

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with...

  • Quality Manager

    il y a 1 semaine


    Bruxelles, Région de Bruxelles, Belgique HNM Solutions Temps plein

    Job ID:HNMJD2697:Role: Quality ManagerLocations: Brussels, Belgium Must have Skills (Demonstrable experience required):You are an experienced Quality project leader with at least 3 years of experience, within a highly regulated environment. You're ability for attention to detail is one of your strengths. You are experienced in either software system testing,...

  • QA Expert Quality System

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Mithra Pharmaceuticals SA Temps plein

    Overview:QA Expert Quality System & ComplianceResponsibilities:Be the QA Expert Quality System & Compliance for Mithra Pharmaceuticals SA, Novalon SA, Estetra SRL, Neuralis SA and Mithra R&D SA.Be responsible for maintaining and improving the QMS of Mithra Group.Drive and maintain an appropriate level of compliance to Mithra Group QMS.Drive and maintain an...

  • Quality Assurance Manager

    il y a 1 semaine


    Bruxelles, Région de Bruxelles, Belgique HNM Solutions Temps plein

    Job ID:HNMJD3415:Role: Quality Assurance ManagerLocation: Brussels, BelgiumLanguage: EnglishDescription of the task: The Following tasks will be performed by an external service provider:Elaboration and maintenance of IS quality control procedures. Provision of quality plans and service level agreements. IS Quality control and evaluation. Provision of...


  • Bruxelles, Région de Bruxelles, Belgique SERB Pharmaceuticals Temps plein

    Job Requisition ID:32263Department:QUALITYCategory:QualityLocation:BrusselsDate:12 Jun 2024Come save lives with us Serb Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 400 employees...

  • Quality Advisor

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique BESIX Temps plein

    de l'entrepriseBESIX Group is a leading multidisciplinary Belgian Group, operating in construction, construction, real estate development and concessions. BESIX Group was founded in 1909, and has grown impressively over the years. BESIX Group operates in Northern and Eastern Europe, North and Central Africa and the Middle East through its subsidiary Six...

  • Senior Service Desk Consultant

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Uni Systems Temps plein

    Organisation, implementation and maintenance of (IS) support Coordination of support teams IS Service management Coordination with the project teams Coordination of wiki sites, collaborative sites or social networks Followup of service quality Management and followup of user requests Guidance regarding the use of information systems Management of incidents...

  • Support Manager

    il y a 1 semaine


    Bruxelles, Région de Bruxelles, Belgique Uni Systems Temps plein

    At Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for a professional to join our UniQue Brussels team.In this role, you will have the opportunity to work closely with our customers in the public sector and you will be responsible for developing new business by identifying profitable...

  • Senior Systems Architect

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Scalian Temps plein

    **Senior Systems Architect - Aeronautics (M/F)**We are searching for an experienced Senior Systems Architect - Aeronautics (M/F) at our Bruxelles facility.**Primary Duties and Responsibilities**:Ne rien renseigner ici. Passer directement à l'onglet offre d'emploi pour renseigner les éléments que vous souhaitez.**Required Qualifications**:**Pourquoi...


  • Bruxelles, Région de Bruxelles, Belgique Fuse Engineering Temps plein

    Client detailsA leader in Belgium, the company specializes in Quality control and risk standardization for the construction sector. With over 270 technical experts, they ensure compliance with standards and the safety of complex buildings.DescriptionConduct audits of Environmental Management Systems (ISO 14001), Quality Management Systems (ISO 9001), and CO2...


  • Bruxelles, Région de Bruxelles, Belgique NMBSSNCB Temps plein

    Comment pouvez-vous faire la différence ? En tant que senior manager , votre rôle consiste à assurer que l'exécution des prestations de maintenance restent équivalentes en terme de qualité au niveau de l'ensemble des ateliers de B-TC afin d'assurer la sécurité de nos agents, la sécurité d'exploitation, le respect de nos engagements de...